Dossier Controlling Party definition

Dossier Controlling Party has the meaning set forth in Section 6.3.2.
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Dossier Controlling Party has the meaning set forth in Section 6.3.2. "Effective DateEffective Date1.1(b)" has the meaning set forth in the Introduction.
Sample 1

Examples of Dossier Controlling Party in a sentence

  • The Company hereby continues to employ Employee and Employee hereby accepts the continued employment with the Company for the Term (as defined below), in the position and with the duties and responsibilities set forth in Section 3 below, and upon the other terms and subject to the conditions hereinafter stated.

  • For clarity, the Dossier Controlling Party shall ensure that the Regulatory Dossier is disclosed to the Regulatory Authorities without any modifications except for translations to the local language required by Applicable Law.

Related to Dossier Controlling Party

  • Controlling Party Has the meaning specified in the Intercreditor Agreement.

  • Controlling producer means a producer who directly or indirectly controls an

  • Non-Controlling Party means the party not controlling the defense of any Third Party Action.

  • Free Trade Agreement country end product means an article that—

  • Controlling Affiliate means an Affiliate that directly or indirectly Controls the Hotel and/or Controls the entity that Controls the Hotel.

  • Free Trade Agreement country construction material means a construction material that—

  • investor of a Contracting Party means: (a) A natural person having the nationality of a Contracting Party in accordance with its applicable law; or (b) An enterprise constituted or organised under the applicable law of a Contracting Party; Making or having made an investment in the other Contracting Party's territory.

  • Controlling Entity means an entity which owns, directly or indirectly through one or more intermediaries, (i) a general partnership interest or a Controlling Interest of the limited partnership interests in Borrower (if Borrower is a partnership or joint venture), (ii) a manager's interest in Borrower or a Controlling Interest of the ownership or membership interests in Borrower (if Borrower is a limited liability company), (iii) a Controlling Interest of any class of voting stock of Borrower (if Borrower is a corporation), (iv) a trustee's interest or a Controlling Interest of the beneficial interests in Borrower (if Borrower is a trust), or (v) a managing partner's interest or a Controlling Interest of the partnership interests in Borrower (if Borrower is a limited liability partnership).

  • Third-party filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.

  • Managing Party shall have the meaning set forth in Section 7.2(a).

  • Least developed country construction material means a construction material that—

  • Controlling Noteholder Representative shall have the meaning assigned to such term in Section 6(a).

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • Preparing Party has the meaning set forth in Section 2.04(a)(ii).

  • Designated country construction material means a construction material that is a WTO GPA country construction material, an FTA country construction material, a least developed country construction material, or a Caribbean Basin country construction material.

  • Third Party Applications means online, Web-based applications and offline software products that are provided by third parties and are identified as third-party applications, including but not limited to those listed on the AppExchange and the Reseller Application.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • WTO GPA country construction material means a construction material that—

  • of a specified Person means a person who directly or indirectly through one or more intermediaries controls, is controlled by, or is under common control with, such specified person;

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Controlling Authority means the Minister administering the Tasmanian State Service Act 1984.

  • BRRD Party means any Underwriter subject to Bail-in Powers.

  • Third Party IPR means any Intellectual Property Rights not belonging to either party to this Agreement but used by the Supplier in the creation of the Deliverables and/or in the course of or in connection with the Project.